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# Draft Guide on Breakthrough Device Program
- URL: https://www.fdaweb.com/draft-guide-on-breakthrough-device-program/
- Published: 2017-10-26T12:00:00.000Z
- Updated: 2026-09-14T22:58:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139982

*Federal Register* notice: FDA has made available a draft guidance entitled “Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff” that describes policies the agency intends to use to implement the new Breakthrough Devices Program, which was established by the 21st Century Cures Act. The program supersedes and combines elements from FDA’s Expedited Access Pathway, which was intended to facilitate the development and expedite review of breakthrough technologies, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to premarket approval applications and applied those criteria to other types of device premarket submissions. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-25/pdf/2017-23195.pdf?ref=fdaweb.com).